Biocad's AcellBia is first MAb biosimilar approved by Russia's Ministry of Health

A biosimilar of Swiss drug major Roche’s (ROG: SIX) MabThera (rituximab), to be marketed under the trade name AcellBia, is the first monoclonal antibody (MAb) biosimilar to receive a positive opinion from the Russian regulatory body, says Russia’s leading biotech company Biocad, which has developed the product.

The Russian MoH’s positive opinion on AcellBia is based on the results of a randomized multicenter clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and efficacy of BCD-020 (rituximab biosimilar by Biocad) to the innovator rituximab. The registration clinical study of rituximab biosimilar in CD20-positive indolent non-Hodgkin’s lymphoma patients started in Russia at the end of 2011; by mid-2012, it already involved more than 30 centers in Russia, Ukraine, India, and the South African Republic.

Over $300 million a year spent on MabThera in Russia